FDA proposes updates to mammography regulations

April 2, 2019

The proposed changes address mammographic technology, enhancing quality standards, and improving the way results of screening are handled throughout the healthcare system.

The public comment period is open for a US Food and Drug Administration (FDA) proposal to make major updates to the agency’s regulations on mammography. The changes reflected in the amendment to the Mammography Quality Standards Act of 1992 are aimed at addressing mammographic technology, enhancing quality standards, and improving the way results of screening are handled throughout the healthcare system.

Included in the description of the new rule are projections of the financial impact of the changes. They relate to new breast density reporting requirements that FDA believes could result in fewer deaths and lower costs for breast cancer treatment. Annualized benefits over 10 years, according to the agency, range from a low of $16.27 million to a high of $534.03 million. Annualized costs to mammography facilities over 10 years are estimated to range from $34.96 million to $59.40 million.

If passed, the rule would require, among other things, that:

  • Mammographic reports to patients and healthcare providers include an assessment of breast density and the potential limitations of the results to promote informed healthcare decision-making;

  • Mammographic facilities implement policies and procedures to minimize loss of images and that they transfer original mammograms and copies of reports to patients, healthcare providers and others within specific timeframes;

  • Changes be made to explanatory language for “benign” findings and that three new categories of mammographic assessment be added to existing language to help mammographic facilities more precisely classify and communicate results of exams; and

  • If a facility is closing or will no longer perform mammography, it makes arrangements to give patients and healthcare providers access to mammographic images and reports.

In a press announcement about the proposal, FDA said that the agency is proposing specific language for mammographic reports that would explain how breast density can influence mammography accuracy and encourage patients with dense breasts to talk with a health care provider about how it relates to breast cancer risk and their unique situation. The new categories of mammographic assessment include “known biopsy proven malignancy,” which would help identify cases in which cancer being mammographically evaluated for therapy is already known and identified. 

The public has until June 26, 2019 to comment on the proposed rule, which would be the first amendment to the Mammography Quality Standards Act in more than 20 years. The provisions would be effective 18 months after date of publication of the final rule in the Federal Register.   

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